WO2014045448A1 - センサ挿入装置及びセンサ挿入方法 - Google Patents

センサ挿入装置及びセンサ挿入方法 Download PDF

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Publication number
WO2014045448A1
WO2014045448A1 PCT/JP2012/074442 JP2012074442W WO2014045448A1 WO 2014045448 A1 WO2014045448 A1 WO 2014045448A1 JP 2012074442 W JP2012074442 W JP 2012074442W WO 2014045448 A1 WO2014045448 A1 WO 2014045448A1
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WO
WIPO (PCT)
Prior art keywords
main body
sensor
grip
needle
pressing
Prior art date
Application number
PCT/JP2012/074442
Other languages
English (en)
French (fr)
Japanese (ja)
Inventor
大越隆弘
松本淳
Original Assignee
テルモ株式会社
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by テルモ株式会社 filed Critical テルモ株式会社
Priority to EP12884951.0A priority Critical patent/EP2898828B1/en
Priority to JP2014536541A priority patent/JP5952411B2/ja
Priority to CN201280075570.6A priority patent/CN104582570B/zh
Priority to PCT/JP2012/074442 priority patent/WO2014045448A1/ja
Publication of WO2014045448A1 publication Critical patent/WO2014045448A1/ja
Priority to US14/663,297 priority patent/US9848804B2/en
Priority to HK15107655.4A priority patent/HK1206958A1/zh

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
    • A61B5/14503—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
    • A61B5/14532—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue for measuring glucose, e.g. by tissue impedance measurement
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
    • A61B5/1468—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue using chemical or electrochemical methods, e.g. by polarographic means
    • A61B5/1473—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue using chemical or electrochemical methods, e.g. by polarographic means invasive, e.g. introduced into the body by a catheter
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6846—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive
    • A61B5/6847—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive mounted on an invasive device
    • A61B5/6848—Needles
    • A61B5/6849—Needles in combination with a needle set
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2560/00—Constructional details of operational features of apparatus; Accessories for medical measuring apparatus
    • A61B2560/06—Accessories for medical measuring apparatus
    • A61B2560/063—Devices specially adapted for delivering implantable medical measuring apparatus
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/0002—Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network
    • A61B5/0031—Implanted circuitry

Definitions

  • the present invention relates to a sensor insertion device and a sensor insertion method for inserting a detection unit of a sensor for measuring biological information of a measurement subject (patient) into the measurement subject's body.
  • a sensor is inserted or implanted in the body of a patient (a person to be measured), and an analyte (for example, glucose, pH, cholesterol, protein, etc.) in the patient's blood or body fluid is detected by the sensor.
  • an analyte for example, glucose, pH, cholesterol, protein, etc.
  • a sensor insertion device is used to quickly and easily place the sensor through the patient's skin (see, for example, JP-T-2008-506468).
  • An applicator (sensor insertion device) described in JP-T-2008-506468 includes an insertion needle that is inserted together with the sensor, a plunger subassembly (movement mechanism) that moves the sensor and the insertion needle to puncture, and a sensor. And an attachment unit (an indwelling member). And the electrode unit (signal processor) which has the transmission function which can transmit the detection information (biological information) of the acquired blood glucose level to an external medical device is attached to a sensor.
  • Step [1] A sensor is attached to the sensor insertion device.
  • Step [2] Release by removing the safety mechanism of the insertion needle to make the insertion needle movable.
  • Step [5] The insertion needle is removed from the sensor, and the sensor and the indwelling member are placed in the body (and on the skin) of the measurement subject.
  • Step [6] The sensor insertion device is separated from the subject.
  • steps [1] to [7] in particular, in order to carry out steps [2], [5] and [6], an operator (mainly the person to be measured) presses a button, Complicated work such as releasing the fitting between members constituting the sensor insertion device is required. Therefore, for example, for a person who is unaccustomed to the operation of the sensor insertion device, such as a young person or an elderly person, a problem that it is difficult to handle has become apparent.
  • step [2] the safety mechanism removed in step [2] must be discarded. This increases the amount of waste and thus lacks convenience.
  • the main object of the present invention is to provide a sensor insertion device that can avoid an increase in the number of wastes.
  • Another object of the present invention is to provide a sensor insertion method capable of inserting a sensor into the body of a person to be measured with a simple operation.
  • a sensor insertion device for inserting a detection unit of a sensor for measuring biological information of a measurement subject into the measurement subject's body,
  • An apparatus main body to which a signal processor for processing a signal including biological information detected by the detection unit is attached;
  • a moving mechanism that is detachably attached to the apparatus main body and moves the detection unit together with an insertion needle that punctures into the body of the subject, thereby inserting the detection unit and the insertion needle into the body of the subject.
  • a displacement preventing member for preventing displacement of the movement mechanism toward the body of the person to be measured;
  • the moving mechanism includes a hollow guide member that can be engaged with the apparatus main body, A needle holding member that presses and moves the insertion needle inside the guide member; A grip member to be gripped by an operator; A pressing member that is held by the grip member and that is displaced so as to press the needle holding member in conjunction with the grip member being displaced along the guide member by the operator; A resilient member that resiliently biases the needle holding member in a direction away from the apparatus main body;
  • the displacement prevention member dams the grip member when the signal processor is not attached to the apparatus main body, and presses the signal processor when the signal processor is attached to the apparatus main body.
  • the pressing member moves down to release the weir against the grip member,
  • the pressing member is displaced following the displacement of the grip member released from the damming of the displacement preventing member toward the subject's body, and the pressing member presses the needle holding member.
  • the insertion needle is punctured into the body of the subject.
  • the pressing member reaches the displacement end point
  • the pressing member is engaged with the guide member in a state in which the holding by the grip member is maintained
  • the guide member is released from engagement with the apparatus main body by the grip member when the grip member and the pressing member reach a displacement end point
  • the needle holding member is displaced in a direction away from the apparatus main body by the action of the elastic member when the grip member and the pressing member reach a displacement end point
  • the pressing member and the guide member are engaged, the engagement of the guide member to the device main body is released, and the needle holding member is displaced in a direction away from the device main body, and the detection unit is in the body.
  • a sensor insertion device that is placed in a
  • a safety mechanism is configured by damming the grip member with a displacement prevention member, and the safety mechanism is released by a simple and essential operation in the sensor insertion process of attaching a signal processor. I have to. Therefore, an erroneous operation for inserting the insertion needle and the detection unit into the body of the measurement subject without attaching the signal processor is prevented.
  • the detection unit is inserted into the body only by performing a simple operation of displacing the moving mechanism toward the body of the person to be measured.
  • the moving mechanism is detached from the apparatus main body. Therefore, even if a person unfamiliar with the sensor insertion device operates, it is difficult to cause an erroneous operation.
  • a rod-like member attached to the guide member can be cited.
  • the rod-shaped member in order to rotate the rod-shaped member, the rod-shaped member may be directly pressed by a signal processor.
  • the lid member is a displacement prevention member. You may make it do.
  • the base member is displaced by pressing the base member with the signal processor. Accordingly, the lid member rotates to release the dam for the grip member. As a result, the safety mechanism is released.
  • the needle holding member In order to displace the needle holding member in a direction away from the apparatus main body under the action of the elastic member when the grip member and the pressing member reach the displacement end point, for example, the needle holding member is a long object. It is only necessary to form a notch extending along the longitudinal direction.
  • the approach part which approachs into the said notch is provided in the said press member.
  • the needle holding member is displaced in a direction away from the apparatus main body under the action of the elastic member.
  • the engaging portion of the guide member with respect to the apparatus main body is expanded toward the outside of the guide member. What is necessary is just to form in the front-end
  • the expanding portion is pressed by the inner wall of the grip member when the grip member is displaced toward the apparatus main body, and as a result, is moved away from the apparatus main body in a direction approaching the guide member side. Displace in the direction. Thereby, the engagement of the engagement portion with the apparatus main body is released.
  • a capturing unit for capturing the sensor when the needle holding member reaches the displacement end point in the apparatus main body.
  • the sensor is positioned and fixed by the capturing unit, so that the detection unit inserted into the body of the measurement subject can be easily detached from the needle. . That is, the detection unit is prevented from coming off.
  • a transmitter is attached to the apparatus body as the signal processor. Since the transmitter can perform wireless transmission, for example, the biological information of the measurement subject can be obtained by an external medical device such as a display or an electronic medical record.
  • the detection unit of the sensor that measures the biological information of the measurement subject is connected to the apparatus main body that holds the signal processor that processes the signal including the biological information detected by the detection unit.
  • a needle holding member that presses and moves the insertion needle inside the guide member;
  • a pressing member that is held by the grip member and that is displaced so as to press the needle holding member in conjunction with the grip member being displaced along the guide member by the operator;
  • a resilient member that resiliently biases the needle holding member in a direction away from the apparatus main body;
  • a displacement preventing member that prevents displacement of the moving mechanism toward the body side of the subject by damming the grip member is provided, The apparatus main body to which the moving mechanism is attached is brought into contact with the measurement subject by engaging the guide member, and the
  • the insertion member is punctured into the body of the subject by displacing the pressing member so as to press the needle holding member in conjunction with the grip member released from the damming of the displacement preventing member. And moving the sensor together, The grip member, the pressing member, and the needle holding member are made to reach a displacement end point, and the pressing member is engaged with the guide member while being held by the grip member, and the guide member is gripped. The member is released from engagement with the apparatus main body, and the needle holding member is displaced in a direction away from the apparatus main body by the action of the elastic member, so that the detection unit is placed in the body. Steps, A sensor insertion method is provided.
  • the safety mechanism can be released only by performing an operation of attaching the signal processor to the apparatus main body.
  • the operator only needs to perform an operation of displacing the moving mechanism toward the body of the person to be measured thereafter, and inserts the sensor detection unit into the body of the person to be measured and allows the moving mechanism to be detached from the apparatus main body. Can do.
  • this sensor insertion method has a small number of operation steps. Therefore, even if a person unfamiliar with the sensor insertion device operates, it is difficult for an erroneous operation to occur, and thus it is difficult for the subject to measure.
  • the displacement prevention member can be configured as a rod-like member attached to the guide member as described above.
  • the rod-shaped member may be rotated by directly pressing the rod-shaped member with a signal processor.
  • the lid member can be a displacement prevention member.
  • the base member may be pressed and displaced by the signal processor, and the lid member may be rotated accordingly.
  • the needle holding member In order to displace the needle holding member in the direction away from the apparatus main body under the action of the elastic member when the grip member and the pressing member reach the end point of displacement, the needle holding member is configured as described above.
  • the entry part may be made to enter the notch over the stopper.
  • the guide member In order to release the guide member from the engagement of the apparatus main body when the grip member and the pressing member reach the displacement end point, the guide member is configured as described above, and the inner wall of the grip member that is displaced toward the apparatus main body side is used. What is necessary is just to displace the engaging part in the direction away from the said apparatus main body by pressing an expansion part.
  • a capturing unit is provided in the apparatus main body, and the sensor is captured by the capturing unit when the needle holding member reaches the displacement end point. This is because the detection unit is prevented from coming off when the needle holding member returns in a direction away from the apparatus main body.
  • FIG. 1 is an overall schematic perspective view of a sensor insertion device according to a first embodiment of the present invention.
  • FIG. 2 is an exploded perspective view of the sensor insertion device.
  • FIG. 3 is a schematic perspective view showing the base member constituting the apparatus main body in relation to the position of the sensor.
  • FIG. 4 is a schematic perspective view from below of a housing constituting the apparatus main body.
  • FIG. 5 is a schematic perspective view from below of a lid member constituting the apparatus main body.
  • FIG. 6 is a schematic perspective view from below of a transmitter attached to the apparatus main body.
  • FIG. 7 is a main part schematic perspective view showing a positional relationship among the grip member, the lid member, the needle holder (needle holding member), the safety bar, and the sensor.
  • FIG. 1 is an overall schematic perspective view of a sensor insertion device according to a first embodiment of the present invention.
  • FIG. 2 is an exploded perspective view of the sensor insertion device.
  • FIG. 3 is a schematic perspective view showing
  • FIG. 8 is a schematic perspective view of a guide member to which a safety bar is attached.
  • FIG. 9 is a schematic perspective view from above of the guide member.
  • FIG. 10 is an overall schematic perspective view of the needle holder (needle holding member).
  • FIG. 11 is an enlarged perspective view of a main part of the needle holder.
  • FIG. 12 is a longitudinal sectional view of the sensor insertion device before the moving mechanism is displaced.
  • FIG. 13 is a lower plan view showing the positional relationship among a grip member, a lid member, a needle holder, a coil spring (bounce member), a safety bar, and a sensor.
  • FIG. 14 is an overall schematic perspective view of the pusher (pressing member).
  • FIG. 14 is an overall schematic perspective view of the pusher (pressing member).
  • FIG. 15 is a longitudinal sectional view of the sensor insertion device showing a state where the lock of the safety bar is released as the transmitter is attached to the device main body.
  • FIG. 16 is a longitudinal sectional view of the sensor insertion device showing a state in which the moving mechanism is displaced toward the subject's body and the coil spring is compressed.
  • FIG. 17 is a schematic perspective view showing the base member in a positional relationship when the sensor is captured by the capturing unit provided on the base member.
  • FIG. 18 is a longitudinal sectional view of the sensor insertion device showing a state in which the coil spring is extended and the needle holding member is displaced in a direction away from the body side of the person to be measured.
  • FIG. 19 is a main part schematic perspective view showing a state in which the moving mechanism is detached from the apparatus main body.
  • FIG. 20 is an exploded perspective view of the sensor insertion device according to the second embodiment of the present invention.
  • FIG. 21 is a schematic perspective view from below of a lid member constituting the apparatus main body of the sensor insertion apparatus according to the second embodiment.
  • FIG. 22 is a schematic perspective view of a main part from below of a grip member constituting a moving mechanism of the sensor insertion device according to the second embodiment.
  • FIG. 23 is a longitudinal sectional view of the sensor insertion device according to the second embodiment before the transmitter is attached to the device main body.
  • FIG. 24 is a main part schematic perspective view showing the positional relationship between the base member and the housing of the apparatus main body before the transmitter is attached to the apparatus main body.
  • FIG. 25 is a main part schematic perspective view showing the positional relationship between the base member, the housing and the transmitter when the transmitter is attached to the apparatus main body from FIG. 24 and the housing is moved forward (displaced).
  • FIG. 26 is a longitudinal sectional view of the sensor insertion device according to the second embodiment after the transmitter is attached to the device main body.
  • FIG. 1 is an overall schematic perspective view of the sensor insertion device 10 according to the first embodiment
  • FIG. 2 is an exploded perspective view thereof.
  • This sensor insertion device 10 includes a device main body 14 to which a transmitter 12 (see FIG. 2) as a signal processor is attached, and a moving mechanism 16, and as shown in FIG. 1, the skin of a patient (measured person). It is used at an appropriate position on S (for example, an inconspicuous place with little body movement such as the abdomen).
  • the sensor insertion device 10 is positioned on the skin S by the adhesive paper 18 provided on the bottom surface of the device main body 14.
  • the adhesive paper 18 is coated on the lower end surface side with an adhesive having a sufficient adhesive force that does not easily peel off even if it is attached to the patient's skin S, and also on the portion facing the apparatus main body 14 on the upper end surface side. Adhesive is coated.
  • the apparatus main body 14 will be described first.
  • the apparatus main body 14 includes a base member 20, a housing 22 attached to the base member 20, and a lid member 24 for closing the opening of the housing 22 (see FIG. 2).
  • the base member 20 includes a first attachment portion 26, a substrate holding portion 28, and a second attachment portion 30.
  • the first mounting portion 26 has two thick rising portions 34a and 34b rising from the bottom frame portion 32, and in the vicinity of the bottom portions of the vertical walls facing each other of the rising portions 34a and 34b, The engaged recesses 36 are recessed.
  • first insertion grooves 38a and 38b and second insertion grooves 40a and 40b are formed along the longitudinal direction of the base member 20 on the outer side surfaces and the top surfaces of the rising portions 34a and 34b, respectively.
  • the substrate holding unit 28 is disposed between the rising portions 34a and 34b and holds the substrate 44 on which the connector 42 is provided.
  • an insertion port 48 for passing an insertion needle 46 described later is formed at the tip of the substrate holding unit 28. Further, a catching claw portion 54 (capturing portion) for capturing the sensor base 52 constituting the sensor 50 is provided above the insertion port 48. Further, a lock portion 55 is provided at the rear end of the substrate holding portion 28 to prevent a safety bar 106 (see FIG. 1), which will be described later, from being displaced when the transmitter 12 is not attached to the base member 20. It is done.
  • the second attachment portion 30 is a portion for attaching the transmitter 12 (see FIG. 6), and the gripping claw portions 56a and 56b are formed to project vertically upward. Furthermore, a damming portion 58 in which a substantially semi-cylindrical body is lying on the end is provided.
  • the housing 22 is substantially U-shaped, and as shown in FIG. 4, first prism portions 60 a and 60 b are formed in the inner side of the side wall so as to protrude in the horizontal direction, and the second prism portion is formed on the ceiling wall. 62a and 62b are formed so as to protrude vertically downward.
  • the first prisms 60a and 60b are slidably inserted into the first insertion grooves 38a and 38b, and the second prisms 62a and 62b are slidably inserted into the second insertion grooves 40a and 40b.
  • the housing 22 has a substantially cylindrical shape at the front end thereof, and is provided with locking shafts 64a and 64b for locking the lid member 24.
  • arc-shaped concave portions 66a and 66b into which the locking shafts 64a and 64b are inserted are formed at the tip of the lid member 24 as shown in FIG. As the locking shafts 64a and 64b are inserted into the arcuate recesses 66a and 66b, the lid member 24 is tiltably locked to the housing 22.
  • hooking claws 68a, 68b are formed to project vertically downward.
  • the hooking claws 68a and 68b are hooked on the ceiling wall of the housing 22 when the lid member 24 is in the closed state.
  • the transmitter 12 attached to the second attachment portion 30 is electrically connected to the substrate 44 by the electrode 70 shown in FIG. 6 to receive a signal, and converts the signal into information to convert an external medical device (not shown) (for example, , For wireless transmission to a display or an electronic medical chart) automatically or by operation.
  • an external medical device for example, , For wireless transmission to a display or an electronic medical chart
  • the blood glucose level of the person to be measured can be managed at a location away from the person to be measured.
  • gripping grooves 72a and 72b into which gripping claws 56a and 56b (see FIG. 3) are inserted are recessed. Further, an entry recess 74 into which the damming part 58 enters is formed at the bottom of one end.
  • the transmitter 12 is attached to the apparatus main body 14 before the sensor insertion device 10 inserts the detection unit 76 (see FIG. 2) of the sensor 50 into the body of the measurement subject.
  • the moving mechanism 16 is for moving the detection unit 76 shown in FIG. 2 in the direction to be inserted into the body of the measurement subject together with the insertion needle 46.
  • the sensor 50 includes the detection unit 76 and the sensor base 52.
  • the detection part 76 in this is formed in elongate, and is accommodated in the insertion needle 46 as shown in FIG.3 and FIG.7.
  • the detection unit 76 detects, for example, information on the glucose concentration (biological information: blood sugar level) contained in the body fluid component of the patient.
  • the sensor base 52 is formed in a thin plate shape and connected to the base end side of the detection unit 76.
  • a rectangular captured hole 78 through which the tip of the capturing claw 54 passes is formed through the sensor base 52.
  • the sensor base 52 is covered with an insulating material, and a sensor circuit (not shown) is provided therein.
  • a sensor circuit using a fluorescent dye for example, a structure in which a substrate made of silicon or the like, a light receiving element, a protective film, a filter, a light emitting element, an indicator layer, and the like are stacked is applied.
  • the sensor base 52 is provided with a flexible cable 80 for electrically connecting the detector 76 and the transmitter 12.
  • Information such as glucose concentration detected by the detection unit 76 is sent to the transmitter 12 via the flexible cable 80 and the connector 42.
  • the insertion needle 46 is made of a rigid metal material (for example, stainless steel) so that the patient's skin S can be easily punctured, and a part of the distal end portion thereof. Is cut and formed to have an acute angle (sharpness) that is easy to puncture the skin S.
  • a rigid metal material for example, stainless steel
  • the insertion needle 46 has a horizontal cross section formed in a substantially C shape (or a substantially U shape), and a hollow groove is defined inside thereof.
  • the hollow groove extends along the longitudinal direction of the insertion needle 46 and can accommodate the detection unit 76 of the sensor 50. That is, the detection unit 76 is covered with the insertion needle 46.
  • the moving mechanism 16 includes a guide member 82 that can be engaged with the apparatus main body 14, a needle holder 84 (needle holding member) that moves the insertion needle 46 by pressing, and a grip by an operator.
  • the guide member 82 is provided as a hollow body slightly inclined with respect to the vertical direction. That is, the insertion hole 92 is formed in the guide member 82 along the longitudinal direction thereof.
  • a holding wall 94 is provided inside the guide member 82 so as to narrow the insertion hole 92 (see FIG. 9).
  • One end of the coil spring 90 is seated on the holding wall 94. In other words, the coil spring 90 is held by the holding wall 94.
  • Two cutout grooves 96a and 96b are formed on both side walls on the long side of the guide member 82 (see FIG. 8), and the portion between the cutout grooves 96a and 96b is formed outward of the guide member 82. It is expanding to head. Hereinafter, this portion is referred to as an expanded portion, and its reference numeral is 98.
  • An engaging protrusion 100 is formed at the tip of the expanded portion 98. These engaging protrusions 100 are engaged with engaged recesses 36 (see FIG. 3) formed in the base member 20 constituting the apparatus main body 14.
  • two shaft support portions 102a and 102b are formed to project from one side wall of the short side of the guide member 82.
  • a pivot shaft 108 of a safety bar 106 (bar-shaped member) that is a displacement preventing member is pivotally supported in the support holes 104 of the shaft support portions 102a and 102b.
  • a first locking window 110 and a second locking window 111 are formed through the same side wall in this order from below.
  • the safety bar 106 is formed as a long object, and a pressed portion 112 is formed so as to protrude at one lower end portion so as to be substantially orthogonal to the longitudinal direction.
  • a locking recess 113 that engages with the locking portion 55 (see FIG. 3) is formed on the lower end surface of the pressed portion 112 so as to be depressed upward.
  • a rotation shaft 108 inserted into the support hole 104 of the shaft support portions 102a and 102b is provided at a substantially middle portion in the longitudinal direction so as to protrude along the width direction.
  • the wide part 114 expanded in the width direction is provided at one end part above the safety bar 106.
  • the needle holder 84 is passed through the insertion hole 92 of the guide member 82. As shown in FIG. 10, the needle holder 84 has a needle holding portion 116 that holds the insertion needle 46, a long body portion 118, and a wide head portion 120 in this order from the bottom to the top.
  • the needle holding part 116 is formed with a notch part 122 so that a part thereof is notched at approximately 90 °, and adjacent to the notch part 122.
  • a holding portion 124 is formed to protrude.
  • the notch 122 is formed with a needle step 126 provided with the insertion needle 46, while the base holding portion 124 is formed with a base step 128 with which the sensor base 52 abuts (FIG. 7). And FIG. 11).
  • the notch portion 122 the flexible cable 80 is prevented from interfering with the needle holding portion 116.
  • the needle holder 84 is formed with a notch 130 from the head 120 to the body 118. Further, a stopper 132 bulging in a direction substantially perpendicular to the longitudinal direction of the notch 130 is provided in the vicinity of the head 120 of the notch 130.
  • the body 118 of the needle holder 84 is passed through the coil spring 90. Further, one upper end of the coil spring 90 is seated on the lower end surface of the head 120. That is, the coil spring 90 is located between the holding wall 94 of the guide member 82 and the head 120 of the needle holder 84.
  • the grip member 86 is provided as a hollow member inclined corresponding to the guide member 82 as shown in FIGS.
  • a surrounding wall 134 for surrounding and holding the guide member 82 is provided inside the grip member 86. Further, in the vicinity of the short inclined surface, two pressing column portions 136 a and 136 b are provided so as to extend along the longitudinal direction of the grip member 86.
  • the clearance between the presser column parts 136a and 136b is set smaller than the width direction dimension of the wide part 114 of the safety bar 106. Therefore, the safety bar 106 is blocked by the presser column parts 136a and 136b. It is in the state that was done.
  • an engagement hole 138 (see FIGS. 1 and 2) is formed through the flat upper end surface of the grip member 86.
  • the pusher 88 includes a head 140 having a shape in which the top of the quadrangular pyramid is removed, and a first hanging part 142 that hangs from two long sides among the four sides of the bottom surface of the head 140.
  • a second drooping portion 144 and an entry portion 146 provided between the first drooping portion 142 and the second drooping portion 144 and extending in the same direction as the first drooping portion 142 and the second drooping portion 144.
  • Have The first hanging portion 142 and the second hanging portion 144 are provided at positions facing each other.
  • the head 120 of the needle holder 84 is slidably held between the first hanging portion 142 and the second hanging portion 144.
  • the front end of the first hanging portion 142 is folded back so as to go outward of the first hanging portion 142, thereby forming a return portion 148.
  • the return portion 148 is locked to the second locking window 111 of the guide member 82.
  • the second hanging portion 144 extending along the insertion hole 92 is held by the insertion hole 92.
  • the entry portion 146 faces the notch 130 of the needle holder 84, and its tip abuts on the stopper 132. That is, the entry portion 146 presses the needle holder 84 by pressing the stopper 132. When the needle holder 84 displaced by this pressing reaches the displacement end point, the entry portion 146 gets over the stopper 132 and enters the cut 130.
  • engagement grooves 150a and 150b are formed on two side surfaces on the short side of the bottom surface, respectively. As shown in FIGS. 1, 12, and the like, a part of the head 140 is passed through the engagement hole 138 from the inside of the grip member 86 and exposed from the engagement hole 138.
  • the engagement hole 138 of the grip member 86 causes elastic deformation and expands.
  • the contraction is restored to the original shape.
  • the inner wall of the engagement hole 138 enters the engagement grooves 150a and 150b.
  • the pusher 88 and the grip member 86 are engaged with each other.
  • the sensor insertion device 10 is basically configured as described above. Next, its operation and effect will be described in relation to an operation (sensor insertion method).
  • the lock portion 55 (see FIG. 3) of the base member 20 is engaged with the locking recess 113 formed on the lower end surface of the pressed portion 112 of the safety bar 106, thereby preventing the displacement of the safety bar 106.
  • the transmitter 12 is attached to the apparatus main body 14 in a state of being present. That is, the gripping claws 56a and 56b are inserted into the gripped grooves 72a and 72b formed on both sides of the transmitter 12, and the transmitter 12 is slid toward the first mounting portion 26 in this state. This sliding ends when the front end surface of the transmitter 12 abuts the rear end surface of the housing 22 and the damming portion 58 enters the entry recess 74. That is, the transmitter 12 is attached to the second attachment portion 30 of the base member 20.
  • the pressed portion 112 of the safety bar 106 is pressed from the distal end surface of the transmitter 12 as shown in FIG.
  • the locking concave portion 113 formed on the lower end surface of the pressed portion 112 is detached from the locking portion 55 (both see FIG. 2), so that the safety bar 106 is restrained from the base member 20 (device main body 14).
  • the safety bar 106 rotates about the rotation shaft 108, and accordingly, the wide portion 114 of the safety bar 106 is detached from the pressing column portions 136 a and 136 b of the grip member 86.
  • the holding column portions 136a and 136b are blocked by the wide portion 114. It cannot be displaced. That is, when the transmitter 12 is not attached, the insertion needle 46 and the detection unit 76 cannot be moved. For this reason, it is possible to prevent an erroneous operation to insert the insertion needle 46 and the detection unit 76 into the body without attaching the transmitter 12.
  • the lid member 24 is accommodated in the grip member 86 so as to be sandwiched between the inner wall of the grip member 86 and the surrounding wall 134.
  • the locking shafts 64a and 64b (see FIG. 4) formed in the housing 22 are inserted in advance into the arc-shaped recesses 66a and 66b (see FIG. 5) of the lid member 24.
  • the return portion 148 of the pusher 88 is locked to a second locking window 111 formed in the vicinity of the upper end portion of the guide member 82, whereby the grip member 86 and the pusher 88 are detached from the apparatus main body 14. It is prevented from moving away from the guide member 82 by moving in the separating direction.
  • the release paper attached to the lower end surface side of the adhesive paper 18 is peeled off, and the adhesive paper 18 is attached to an appropriate position on the patient's skin S.
  • the sensor insertion device 10 is positioned on the skin S.
  • the operator grasps the grip member 86 and pushes down the grip member 86 along the guide member 82 as shown in FIG. That is, the grip member 86 is displaced toward the measurement subject's body. Following this, the pusher 88 engaged with the grip member 86 is also displaced. Since the lock by the safety bar 106 has already been released as described above, this displacement is easy.
  • the needle holder 84 Since the entry portion 146 of the pusher 88 is in contact with the stopper 132 of the needle holder 84, the needle holder 84 is also displaced in the same direction as the grip member 86 and the pusher 88 as the pusher 88 is displaced. Accordingly, the insertion needle 46 held by the needle holding portion 116 of the needle holder 84 and the detection portion 76 accommodated in the insertion needle 46 move toward the body side of the measurement subject. That is, the insertion needle 46 and the detection unit 76 pass through the insertion port 48 (see FIG. 3) of the base member 20 and are inserted into the body of the measurement subject. Further, the return portion 148 is detached from the second locking window 111, and the coil spring 90 is compressed.
  • the expanded portion 98 of the guide member 82 is gradually accommodated inside the grip member 86 as the grip member 86 is displaced. For this reason, the expanding part 98 is pressed toward the guide member 82 side by the inner wall of the grip member 86. As a result, a force directed in a direction away from the engaged recessed portion 36 acts on the engaging protrusion 100 provided at the tip of the expanded portion 98. Therefore, the engaging protrusion 100 is gradually separated from the engaged recess 36 as the grip member 86 is displaced.
  • the grip member 86 When the grip member 86 reaches the displacement end point, the displacement of the pusher 88 and the needle holder 84 is finished, and the insertion of the insertion needle 46 and the detection unit 76 is also finished. At this time, the position of the captured hole 78 of the sensor base 52 matches the capturing claw 54 of the apparatus main body 14 (base member 20), and the tip of the capturing claw 54 is captured as shown in FIG. Pass through hole 78.
  • the sensor base 52 is positioned and fixed to the apparatus main body 14, so that the detection unit 76 is prevented from coming off from the body. Further, the flexible cable 80 is not twisted.
  • the engaging protrusion 100 provided at the tip of the expanded portion 98 of the guide member 82 is separated from the engaged recess 36.
  • the engagement of the guide member 82 with the apparatus main body 14 is released, and the moving mechanism 16 is disconnected from the apparatus main body 14.
  • the entry portion 146 gets over the stopper 132 provided on the needle holder 84. That is, the entry portion 146 enters the cut 130 (see FIG. 16).
  • the needle holder 84 is released from the pressing of the pusher 88. Therefore, as shown in FIG. 18, the compressed coil spring 90 expands and returns to its original shape, and at this time, the needle holder 84 is elastically biased. As a result, the needle holder 84 is displaced obliquely upward along the guide member 82, in other words, in a direction away from the apparatus main body 14. Following this, the insertion needle 46 is also displaced obliquely upward, so that the insertion needle 46 is removed from the body of the subject.
  • FIG. 17 shows the state at this time.
  • the sensor base 52 is held by the catching claw 54 as described above. Accordingly, it is possible to avoid the movement of the sensor 50 as the needle holder 84 is displaced and the detection unit 76 from coming out of the body of the measurement subject.
  • the return portion 148 of the pusher 88 is locked to the first locking window 110 of the guide member 82. That is, the pusher 88 is engaged with the guide member 82.
  • the moving mechanism 16 is detached from the apparatus main body 14 integrally. That is, in the first embodiment, the safety mechanism is released by simply performing the simple operation of attaching the transmitter 12 to the apparatus main body 14 and then holding the grip member 86 and pushing it down to the body side. It is possible to insert the detection unit 76 into the body of the person to be measured, and to leave only the apparatus main body 14 on the body and detach the moving mechanism 16 from the apparatus main body 14. Therefore, even if a person unfamiliar with the sensor insertion device 10 operates, it is difficult to cause an erroneous operation.
  • the insertion needle 46 is housed inside the guide member 82. For this reason, it is avoided that the insertion needle 46 is stabbed into the operator who handles the moving mechanism 16 after separation, and the surrounding person. That is, erroneous insertion of the insertion needle 46 can be prevented.
  • the lid member 24 housed in the grip member 86 is exposed.
  • the lid member 24 is rotated about the locking shafts 64a and 64b as a rotation center to be closed, and the opening of the housing 22 is closed.
  • the hooking claws 68 a and 68 b are caught on the ceiling wall of the housing 22.
  • an analyte for example, glucose, pH, cholesterol, protein, etc.
  • a detection result by the detection unit 76 is transmitted as a signal from the sensor base 52 to the connector 42 via the flexible cable 80. Further, the signal is received by the transmitter 12 through the electrode 70, converted into information, and wirelessly transmitted to the medical device (that is, a display device, an electronic medical record, etc.) automatically or by operation.
  • the medical device that is, a display device, an electronic medical record, etc.
  • the biological information of the measurement subject can be obtained.
  • FIG. 20 is an exploded perspective view of the sensor insertion device 210 according to the second embodiment.
  • the sensor insertion device 210 includes a device main body 214 to which the transmitter 12 (see FIG. 2) is attached, and a moving mechanism 216. Like the sensor insertion device 10, the sensor insertion device 210 is connected to a patient (measured person) via an adhesive paper 18. ) And attached to an appropriate position on the skin S.
  • the apparatus main body 214 will be described first.
  • the apparatus main body 214 includes a base member 20, a housing 22 attached to the base member 20, and a lid member 224 that closes the opening of the housing 22.
  • a dent recess 226 is formed in one end of the lid member 224. Further, similarly to the lid member 24, arc-shaped concave portions 66a and 66b into which the locking shafts 64a and 64b of the housing 22 are inserted are formed at the other end portion, and a latching claw is formed at the lower end surface thereof. The portions 68a and 68b are formed so as to project vertically downward.
  • this lid member 224 is also pivotally locked to the housing 22 as the locking shafts 64a and 64b are inserted into the arc-shaped recesses 66a and 66b, and when the lid member 224 is in the closed state, The hooking claws 68 a and 68 b are caught on the ceiling wall of the housing 22.
  • the moving mechanism 216 is for moving the detection unit 76 of the sensor 50 shown in FIG. 20 in the direction to be inserted into the body of the measurement subject together with the insertion needle 46.
  • the moving mechanism 216 includes a guide member 282 that can be engaged with the apparatus main body 214, a needle holder 84 (needle holding member) that presses and moves the insertion needle 46, and an operation.
  • a grip member 286 held by a person a pusher 88 (pressing member) that presses the needle holder 84, and a coil spring 90 (elastic member) that elastically biases the needle holder 84.
  • the guide member 282 is configured in accordance with the guide member 82 except that the shaft support portions 102a and 102b shown in FIGS. 8 and 9 are not provided. Therefore, the same reference numerals are assigned to the same parts as the respective parts of the guide member 82, and the description thereof is omitted.
  • the inner wall of the long inclined surface of the grip member 286 has a shape in which a part thereof is cut out, and thus a step 288 is formed.
  • the stepped portion 288 enters a blocking recess 226 (see FIG. 21) formed at one end of the lid member 224.
  • a surrounding wall 134 for surrounding and holding the guide member 282 is further provided.
  • An engagement hole 138 is formed through the flat upper end surface.
  • the housing 22 is slidably held on the base member 20 with its rear end surface slightly protruding from the rising portions 34a and 34b. .
  • the first prism portions 60a and 60b are slidably inserted into the first insertion grooves 38a and 38b, and the second prism portions 62a and 62b slide into the second insertion grooves 40a and 40b. Inserted as possible.
  • the blocking recess 226 of the lid member 224 has entered the step 288 of the grip member 286 (see FIG. 23).
  • the grip member 286 is blocked by the lid member 224, and the grip member 286 is in a locked state in which the grip member 286 is prevented from being displaced toward the body side of the measurement subject. That is, the detector 76 cannot be inserted into the body of the subject without the transmitter 12 attached.
  • the lid member 224 functions as a displacement prevention member. For this reason, it is possible to prevent an erroneous operation to insert the insertion needle 46 and the detection unit 76 into the body without attaching the transmitter 12.
  • the transmitter 12 is attached to the apparatus main body 214. That is, the gripping claws 56a and 56b are inserted into the gripped grooves 72a and 72b formed on both sides of the transmitter 12, and the transmitter 12 is slid toward the first mounting portion 26 in this state.
  • the front end surface of the transmitter 12 comes into contact with the rear end surface of the housing 22. This is because the rear end surface of the housing 22 slightly protrudes from the rising portions 34a and 34b as described above (see FIG. 24).
  • the housing 22 is pressed by the sliding transmitter 12 and moves forward (displaces) in a direction away from the second mounting portion 30.
  • the displacement of the housing 22 and the sliding of the transmitter 12 are such that the front end surface of the transmitter 12 comes into contact with the rear end surfaces of the rising portions 34a and 34b, and the damming portion 58 provided on the base member 20
  • the process is terminated by entering the entry recess 74 of the transmitter 12 (see FIG. 6).
  • the locking shafts 64 a and 64 b of the housing 22 rotate so that the lid member 224 inserted into the arc-shaped recesses 66 a and 66 b is tilted toward the housing 22.
  • the blocking recess 226 is detached from the stepped portion 288, the blocking of the grip member 286 is released, and the locked state is released.
  • the release paper attached to the lower end surface side of the adhesive paper 18 is peeled off, and the adhesive paper 18 is attached to an appropriate position on the patient's skin S.
  • the sensor insertion device 210 is positioned on the skin S.
  • the operator grips the grip member 286 and pushes down the grip member 286 along the guide member 282.
  • the pusher 88 engaged with the grip member 286 is also displaced. Since the grip member 286 is unlocked by the lid member 224 as described above, this displacement is easy.
  • the process proceeds in the same manner as in the first embodiment. That is, since the entry portion 146 of the pusher 88 is in contact with the stopper 132 of the needle holder 84, the needle holder 84 is also displaced in the same direction as the grip member 286 and the pusher 88 as the pusher 88 is displaced. . Accordingly, the insertion needle 46 held by the needle holding portion 116 of the needle holder 84 and the detection portion 76 accommodated in the insertion needle 46 move toward the body side of the measurement subject. That is, the insertion needle 46 and the detection unit 76 pass through the insertion port 48 (see FIG. 24) of the base member 20 and are inserted into the body of the measurement subject. Further, the return portion 148 of the pusher 88 is detached from the second locking window 111 of the guide member 282, and the coil spring 90 is compressed.
  • the expanded portion 98 of the guide member 282 is gradually accommodated inside the grip member 286 as the grip member 286 is displaced. For this reason, the expansion part 98 is pressed toward the guide member 282 side by the inner wall of the grip member 286. As a result, a force directed in a direction away from the engaged recessed portion 36 acts on the engaging protrusion 100 provided at the tip of the expanded portion 98. Therefore, the engaging protrusion 100 is gradually separated from the engaged recess 36 as the grip member 286 is displaced.
  • the grip member 286 When the grip member 286 reaches the displacement end point, the displacement of the pusher 88 and the needle holder 84 is terminated, and the insertion of the insertion needle 46 and the detection unit 76 is also terminated. At this time, the position of the captured hole 78 of the sensor base 52 coincides with the capturing claw 54 of the apparatus main body 214 (base member 20), and the tip of the capturing claw 54 is the captured hole as in FIG. Go to 78.
  • the detection unit 76 is prevented from being detached from the body. Further, the flexible cable 80 is not twisted.
  • the engaging protrusion 100 provided at the tip of the expanded portion 98 of the guide member 282 is separated from the engaged recess 36.
  • the engagement of the guide member 282 with the apparatus main body 214 is released, and the moving mechanism 216 is disconnected from the apparatus main body 214.
  • the entry portion 146 gets over the stopper 132 provided on the needle holder 84. That is, the entry portion 146 enters the cut 130.
  • the needle holder 84 is released from the pressing of the pusher 88. Accordingly, similarly to FIG. 18, the compressed coil spring 90 expands to return to its original shape, and at this time, the needle holder 84 is elastically biased. As a result, the needle holder 84 is displaced obliquely upward along the guide member 282, in other words, in a direction away from the apparatus main body 214. Following this, the insertion needle 46 is also displaced obliquely upward, so that the insertion needle 46 is removed from the body of the subject.
  • the sensor base 52 is held by the catching claw 54 as described above. Accordingly, it is possible to avoid the movement of the sensor 50 as the needle holder 84 is displaced and the detection unit 76 from coming out of the body of the measurement subject.
  • the return portion 148 of the pusher 88 is locked to the first locking window 110 of the guide member 282. That is, the pusher 88 is engaged with the guide member 282.
  • the moving mechanism 216 is detached from the apparatus main body 214 integrally. That is, also in the second embodiment, the safety mechanism is released by simply performing a simple operation of attaching the transmitter 12 to the apparatus main body 214 and then holding the grip member 286 and pushing it down to the body side. It is possible to insert the detection unit 76 into the body of the person to be measured and to leave only the apparatus main body 214 on the body and to disengage the moving mechanism 216 from the apparatus main body 214.
  • the insertion needle 46 is housed inside the guide member 282, it is possible to prevent erroneous insertion of the insertion needle 46.
  • the lid member 224 is a member constituting the apparatus main body 214. There is an advantage that waste does not increase.
  • the lid member 224 accommodated in the grip member 286 is exposed.
  • the lid member 224 is turned around the locking shafts 64a and 64b to be closed, and the opening of the housing 22 is closed.
  • the hooking claws 68 a and 68 b are caught on the ceiling wall of the housing 22.
  • an analyte for example, glucose, pH, cholesterol, protein, etc.
  • a detection result by the detection unit 76 is transmitted as a signal from the sensor base 52 to the connector 42 via the flexible cable 80. Further, the signal is received by the transmitter 12 through the electrode 70, converted into information, and wirelessly transmitted to the medical device (that is, a display device, an electronic medical record, etc.) automatically or by operation.
  • the medical device that is, a display device, an electronic medical record, etc.
  • the present invention is not particularly limited to the above-described embodiment, and various modifications can be made without departing from the gist thereof.
  • the transmitter 12 may be attached after the sensor insertion devices 10 and 210 are positioned on the skin S.

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PCT/JP2012/074442 2012-09-24 2012-09-24 センサ挿入装置及びセンサ挿入方法 WO2014045448A1 (ja)

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EP12884951.0A EP2898828B1 (en) 2012-09-24 2012-09-24 Sensor insertion device
JP2014536541A JP5952411B2 (ja) 2012-09-24 2012-09-24 センサ挿入装置
CN201280075570.6A CN104582570B (zh) 2012-09-24 2012-09-24 传感器插入装置
PCT/JP2012/074442 WO2014045448A1 (ja) 2012-09-24 2012-09-24 センサ挿入装置及びセンサ挿入方法
US14/663,297 US9848804B2 (en) 2012-09-24 2015-03-19 Sensor insertion device and sensor insertion method
HK15107655.4A HK1206958A1 (zh) 2012-09-24 2015-08-08 傳感器插入裝置及傳感器插入方法

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JP5952411B2 (ja) 2016-07-13
EP2898828A4 (en) 2016-05-25
HK1206958A1 (zh) 2016-01-22
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US20150190076A1 (en) 2015-07-09
US9848804B2 (en) 2017-12-26

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